Our objection is to the fact that one article in the directive states:
an element isolated from the human body or otherwise produced by means of a technical process including the structure or partial structure of a gene may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.
Therefore, as it stands, the directive does mean that naturally occurring gene sequences are patentable because, in order to do anything with a gene or gene sequence, it has to be isolated from the body.
Although an industrial application has to be stated, this can be something as simple as looking for faults in the gene. This means that any genetic test, using any technique, would be subject to the payment of royalties and licence fees. A biomedical company would not have to develop an inventive kit or develop a therapy to earn money. Indeed, rather than encourage the development of these tests and therapies, it would create a monopoly in which only the patent holder would gain, without the necessity to do anything inventive. The actual gene itself would probably never be used in therapy without some vector to deliver it to the body. Therefore, any therapy derived from the gene would be subject to a double patent.
It is the wording of this one article in the directive that is so vital. There is no guarantee that this directive, as it is worded, will help patients with genetic disorders. However, it will cost the NHS dearly, probably restrict access to genetic tests and create a field day for biomedical companies and lawyers.
Director, The Neurofibromatosis Association
Kingston upon Thames, Surrey